Breast CancerNCT02759549
Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH
A study testing eSMART-MH, Mobile Mood Tracking (Mood 24/7) and Theater Testing Workshop in people with Breast Cancer, run by Emory University at 4 sites in United States.
Trial summary
The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- eSMART-MH, Mobile Mood Tracking (Mood 24/7) and Theater Testing Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients seen in the Emory Breast Center at The Emory Clinic and Emory Midtown Hospital who are treated with curative intent.
- Score of 8 or higher on the Inventory of Depressive Symptomology - Self Reported (IDS-SR) test
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital Midtown
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Fatigue in Breast Cancer Patients Undergoing Radiotherapy-Electronic Self-Management Resource Training for Mental Health (eSMART-MH)
The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews.
Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff.
Read the detailed description
The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews.
Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff.
Participants will be enrolled within two weeks of radiotherapy. A preliminary depression survey (IDS-SR) will be given to assess depression. There will be a total of three routine study assessments, one within two weeks prior to the beginning of radiotherapy, one the last week of radiotherapy and one 5 - 7 weeks after radiotherapy is completed.
- Conditions
- Breast Cancer
- Being tested
- eSMART-MH, Mobile Mood Tracking (Mood 24/7), Theater Testing Workshop
- Keywords
- Radiation Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSMART-MHBehavioural
eSMART-MH (Electronic Self-Management Resource Training for Mental Health) is a software, which is set in a 3-D virtual primary care office environment in which a subject interacts with avatar virtual healthcare staff (medical receptionist, medical assistant, providers, and a virtual healthcare coach). The avatars are programmed to behave like humans. The subject moves through the 3-D virtual primary care office and encounters virtual healthcare staff and providers. The subject practices discussing depressive symptoms with avatar healthcare providers and practices self-management skills related to symptoms of depression.The subject also interacts with the health care coach. The health care coach provides the subject with real-time strategies to enhance communication with healthcare providers during their virtual office visit. eSMART-MH will be used once a week throughout the duration of radiation treatment.
Mobile Mood Tracking (Mood 24/7)Other
Public social media data posted by participants will be accessed and downloaded to a computer program. Permission for the study team to access this data is optional.
Theater Testing WorkshopBehavioural
The theater testing workshop consists of one to two one-on-one sessions with study staff during which participants will review a computer program for its content and usability, as well as discuss areas for improvement. Participants will also be asked to complete questionnaires and a attend a brief interview regarding any suggested improvements for the computer program.
| Study group | Role | What they receive |
|---|---|---|
| eSMART-MH | Experimental | Participants undergoing radiation treatment for breast cancer will receive the Electronic Self-Management Resource Training for Mental Health (eSMART-MH) intervention. Receives: Behavioral: eSMART-MH; Other: Mobile Mood Tracking (Mood 24/7) |
| Theater Testing | Other | Participants undergoing radiation treatment for breast cancer will participate in a theater testing workshop. Receives: Behavioral: Theater Testing Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score
The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.
Measured: Baseline, Post Treatment (5-7 weeks)
Secondary outcomes (9)
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality.
Measured: Baseline, Post Treatment (5-7 weeks)
Change in Perceived Stress Scale (PSS) Score
The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress.
Measured: Baseline, Post Treatment (5-7 weeks)
Change in Short Form-36 (SF-36) Health Survey Score
The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability.
Measured: Baseline, Post Treatment (5-7 weeks)
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. A score of 24 or more indicates active and substantial exercise benefits. A score of 23 units or less indicates insufficiently active and less substantial exercise benefits.
Measured: Baseline, Post Treatment (5-7 weeks)
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue.
Measured: Baseline, Post Treatment (5-7 weeks)
Change in Lent Soma Scale Patient Questionnaire Score
The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.
Measured: Baseline, Post Treatment (5-7 weeks)
Change in Multidimensional Fatigue Inventory (MFI) Score
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued.
Measured: Baseline, Post Treatment (5-7 weeks)
Change in The Centers for Disease Control (CDC) Health-Related Quality of Life-4 (QOL) Questionnaire Score
Quality of Life will be measured by the Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL). This self-report measures quality of life over the last 30 days in the domains of physical and mental health.
Measured: Baseline, Post Treatment (5-7 weeks)
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
The FACT-G is a self-reported measure of well being in the past seven days. Scores range from 0 to 27. A higher score indicates worse perception of well being.
Measured: Baseline, Post Treatment (5-7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, Mylin Torres, MD, Emory University
- Investigators
- Mylin Torres, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759549
- Sponsor's protocol ID
- IRB00028295
- Status last verified
- Nov 2016
- First submitted
- 29 Apr 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Breast Cancer Patients Undergoing Radiotherapy-Electronic Self-Management Resource Training for Mental Health (eSMART-MH)
- ClinicalTrials.gov ID
- NCT02759549
- Acronym / sponsor ID
- IRB00028295
- Conditions
- Breast Cancer
- Keywords
- Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews.
Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff.
Detailed description
The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews.
Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff.
Participants will be enrolled within two weeks of radiotherapy. A preliminary depression survey (IDS-SR) will be given to assess depression. There will be a total of three routine study assessments, one within two weeks prior to the beginning of radiotherapy, one the last week of radiotherapy and one 5 - 7 weeks after radiotherapy is completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eSMART-MH | Experimental | Behavioral: eSMART-MH, Other: Mobile Mood Tracking (Mood 24/7)Participants undergoing radiation treatment for breast cancer will receive the Electronic Self-Management Resource Training for Mental Health (eSMART-MH) intervention. |
| Theater Testing | Other | Behavioral: Theater Testing WorkshopParticipants undergoing radiation treatment for breast cancer will participate in a theater testing workshop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients seen in the Emory Breast Center at The Emory Clinic and Emory Midtown Hospital who are treated with curative intent.
- Score of 8 or higher on the Inventory of Depressive Symptomology - Self Reported (IDS-SR) test
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eSMART-MHeSMART-MH (Electronic Self-Management Resource Training for Mental Health) is a software, which is set in a 3-D virtual primary care office environment in which a subject interacts with avatar virtual healthcare staff (medical receptionist, medical assistant, providers, and a virtual healthcare coach). The avatars are programmed to behave like humans. The subject moves through the 3-D virtual primary care office and encounters virtual healthcare staff and providers. The subject practices discussing depressive symptoms with avatar healthcare providers and practices self-management skills related to symptoms of depression.The subject also interacts with the health care coach. The health care coach provides the subject with real-time strategies to enhance communication with healthcare providers during their virtual office visit. eSMART-MH will be used once a week throughout the duration of radiation treatment. | Behavioural | eSMART-MH |
| Mobile Mood Tracking (Mood 24/7)Public social media data posted by participants will be accessed and downloaded to a computer program. Permission for the study team to access this data is optional. | Other | eSMART-MH |
| Theater Testing WorkshopThe theater testing workshop consists of one to two one-on-one sessions with study staff during which participants will review a computer program for its content and usability, as well as discuss areas for improvement. Participants will also be asked to complete questionnaires and a attend a brief interview regarding any suggested improvements for the computer program. | Behavioural | Theater Testing |
Primary outcome
Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score
Time frame: Baseline, Post Treatment (5-7 weeks)
The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.
9 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Change in Perceived Stress Scale (PSS) Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Change in Short Form-36 (SF-36) Health Survey Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Change in Lent Soma Scale Patient Questionnaire Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Change in Multidimensional Fatigue Inventory (MFI) Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Change in The Centers for Disease Control (CDC) Health-Related Quality of Life-4 (QOL) Questionnaire Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
Time frame: Baseline, Post Treatment (5-7 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mylin Torres, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSMART-MH, Mobile Mood Tracking (Mood 24/7) and Theater Testing Workshop in people with Breast Cancer, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score (time frame: Baseline, Post Treatment (5-7 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.